Clinical Update · PSMA

Lutetium-177 PSMA as a first-line treatment for metastatic prostate cancer.

Q: When did the FDA approve Pluvicto for earlier-line use?

The U.S. FDA expanded the Pluvicto label in March 2025 based on the PSMAfore data, removing the prior chemotherapy requirement from the indication. The new indication covers adult patients with PSMA-positive mCRPC who have progressed on at least one ARPI [2]. This was a major shift — the patient population eligible for Pluvicto roughly doubled.

Q: How does PSMAfore compare with VISION?

Both trials produced strikingly similar rPFS hazard ratios (~0.4) despite testing Pluvicto in very different lines: VISION was post-chemotherapy mCRPC (n=831), PSMAfore was pre-chemotherapy mCRPC (n=468). PSA50 response was higher in PSMAfore (57.6% vs 46% in VISION), consistent with earlier-line therapy generally producing stronger response signals. Median rPFS was 12.0 vs 8.7 months in the experimental arms — also reflecting earlier-line vs later-line treatment [1][4].

Q: Why was overall survival not significantly improved in PSMAfore?

Overall survival was not statistically significantly different between arms in the intent-to-treat analysis, primarily because of extensive crossover — approximately 84% of patients on the ARPI-switch arm who progressed crossed over to receive Lu-PSMA. This is a recognised feature of trials where the experimental therapy is also available as salvage; it dilutes the OS signal. The clinical interpretation is not that the treatments are equivalent in efficacy, but that the OS endpoint is confounded by crossover [1].

Q: What is ENZA-p?

ENZA-p is a phase II randomised trial (n=162) that tested combining Lu-PSMA with enzalutamide versus enzalutamide alone as first-line treatment for mCRPC. Median PSA-progression-free survival was 13.0 months in the combination arm versus 7.8 months in enzalutamide alone (HR 0.43). Published in Lancet Oncology in 2024 [7]. ENZA-p extends the Lu-PSMA evidence base even earlier than PSMAfore — into the first-line setting — and supports an additive effect when Lu-PSMA is added to rather than substituted for ARPI.

Q: Is Lu-PSMA combination therapy with ARPI FDA-approved?

No — as of 2026 Lu-PSMA + enzalutamide is not yet FDA-approved as a registered regimen. ENZA-p was a phase II trial with significant findings but typically a phase III trial is required for registration. Phase III trials of Lu-PSMA combinations (with ARPI, with chemotherapy) are ongoing. The current FDA-approved indication for Pluvicto is as monotherapy in PSMA-positive mCRPC after progression on at least one ARPI [2].

Q: Who is a candidate for first-line Lu-PSMA in 2026?

Adult patients with PSMA-positive mCRPC who have progressed on at least one ARPI are now FDA-approved candidates for Pluvicto, without requiring prior chemotherapy. Eligibility requires confirmed PSMA expression on Ga-68 PSMA-11 or F-18 piflufolastat PSMA PET-CT (Krenning score ≥ 2 in target lesions), adequate organ function (kidneys, marrow, liver), ECOG performance status 0-2, life expectancy generally > 6 months, and multidisciplinary review of competing options [2].

The PSMAfore trial design and primary outcomes, the March 2025 FDA label expansion to earlier-line use, ENZA-p combination evidence, and how patient selection actually works in the pre-chemotherapy mCRPC setting. A sourced clinical update.

Dr. Ishita B. Sen, MDDirector & Chief, Nuclear Medicine · FMRI

Published 13 May 2026

Reviewed by Dr. Dharmender Malik

13 min read

Last reviewed by Dr. Dharmender Malik on 13 May 2026 · this article reflects the published primary literature and current clinical practice at FMRI Gurugram.

Introduction

The clinical landscape for Lu-177 PSMA-617 (Pluvicto) changed materially in 2024-2025. The PSMAfore phase III trial — published in NEJM in 2024 — demonstrated that Pluvicto delivered earlier in the mCRPC treatment sequence, before chemotherapy, produced significantly longer radiographic progression-free survival than switching to a different androgen-receptor pathway inhibitor (ARPI)^[1]. On the basis of these data, the U.S. FDA expanded the Pluvicto label in March 2025 to include patients who have progressed on at least one ARPI without requiring prior taxane chemotherapy^[2]. This article is a clinician-focused review of the evidence base for earlier-line Lu-PSMA, the patient selection framework now used in practice, the ENZA-p combination data, and the sequencing implications.

PSMAfore trial design

AI Overview · short answer

PSMAfore was a phase III randomised trial of Lu-177 PSMA-617 (Pluvicto) versus switching to a different ARPI in 468 patients with PSMA-positive mCRPC who had progressed on one prior ARPI and had not yet received taxane chemotherapy. The trial was designed to test whether Lu-PSMA delivered earlier in the treatment sequence would improve outcomes compared with the standard practice of switching ARPIs at first progression^[1].

Key design features:

Population — 468 patients, PSMA-positive mCRPC on Ga-68 PSMA-11 PET-CT (Krenning score ≥ 2 in target lesions and no PSMA-negative measurable lesions exceeding specific criteria).
Prior therapy — progression on one prior ARPI (enzalutamide or abiraterone); no prior taxane chemotherapy.
Randomisation — 1:1 to Pluvicto (7.4 GBq every 6 weeks for up to 6 cycles) versus switching to a different ARPI (e.g., switching from abiraterone to enzalutamide or vice versa).
Primary endpoint — radiographic progression-free survival (rPFS) by independent central review.
Crossover — patients on the ARPI arm who progressed were allowed to cross over to Lu-PSMA — an important factor in interpreting overall survival data^[1].

PSMAfore primary outcomes

The primary and key secondary endpoints from PSMAfore^[1]^[3]:

Outcome	Pluvicto (n=234)	ARPI switch (n=234)	HR / p-value
Median rPFS (primary)	12.0 months	5.6 months	HR 0.43; p < 0.0001
PSA50 response	57.6%	20.4%	—
Objective response rate (RECIST)	50.7%	14.9%	—
Median overall survival	Not significantly different (HR ~1.0)	—	Confounded by crossover
Time to symptomatic skeletal events	Significantly longer	—	Statistically significant
FACT-P quality of life	Improved versus ARPI switch	—	Statistically significant

The headline finding is the 6.4-month rPFS improvement (12.0 vs 5.6 months) — a hazard ratio of 0.43 representing a 57 percent reduction in the risk of progression or death. Critically, the overall survival result was confounded by extensive crossover (~84 percent of ARPI-arm patients who progressed crossed over to Lu-PSMA), which is why OS in the intent-to-treat analysis was not significantly different^[1].

PSMAfore in context — comparison with VISION

The earlier VISION trial established Pluvicto in the post-chemotherapy mCRPC setting. The two trials together define the current Lu-PSMA evidence base^[4]:

Feature	VISION (2021, post-chemo)	PSMAfore (2024, pre-chemo)
n	831	468
Population	Post-ARPI + post-taxane mCRPC	Post-ARPI, taxane-naïve mCRPC
Comparator	Standard of care (heterogeneous)	Switch to a different ARPI
Median rPFS	8.7 vs 3.4 months (HR 0.40)	12.0 vs 5.6 months (HR 0.43)
Median OS	15.3 vs 11.3 months (HR 0.62)	Not significant (crossover-confounded)
PSA50 response	46% vs 7.1%	57.6% vs 20.4%
FDA approval	March 2022	March 2025 (label expansion)

The PSA50 and rPFS rates are higher in PSMAfore than in VISION — consistent with the principle that earlier-line therapy generally produces better response signals because tumours are less heavily pre-treated. The fact that both trials produced strikingly similar rPFS hazard ratios (~0.4) across very different lines of therapy suggests Lu-PSMA produces a relatively consistent benefit across settings^[5].

March 2025 FDA label expansion — what changed

Regulatory · what the label says now

The March 2025 FDA label expansion changed the Pluvicto indication from "PSMA-positive mCRPC after progression on an ARPI and taxane chemotherapy" to "PSMA-positive mCRPC after progression on at least one ARPI" — removing the requirement for prior chemotherapy^[2]. This was a major shift, as it made Pluvicto an option earlier in the treatment sequence for the substantial population of mCRPC patients who progress on first-line ARPI without having had taxane chemotherapy.

Practical implications of the label expansion:

Patient population eligible for Pluvicto roughly doubled. The pre-chemo mCRPC population is substantially larger than the post-chemo population.
Multidisciplinary review framework expanded. Earlier-line use means more patients with longer expected survival, more potential cumulative cycles, and more complex sequencing decisions (when to use Pluvicto vs second ARPI vs taxane vs PARP inhibitor in BRCA-mutated disease).
Crossover-informed counselling. Patients on the second-ARPI arm of PSMAfore who progressed crossed over to Pluvicto at high rates — and many still benefited. This informs how clinicians counsel patients who are weighing earlier Pluvicto versus reserving it for later.
Geographic access variability persists. FDA approval is U.S.-specific; EMA and other regulators are reviewing equivalent expansions. The Indian regulatory landscape for Pluvicto remains evolving^[6].

ENZA-p — Lu-PSMA plus enzalutamide combination

The ENZA-p trial, published in Lancet Oncology in 2024, tested adding Lu-PSMA to enzalutamide versus enzalutamide alone in 162 patients with mCRPC who were starting first-line ARPI therapy^[7]:

Population — 162 patients with mCRPC, PSMA-positive on PET-CT, starting first-line enzalutamide.
Randomisation — enzalutamide + up to 4 cycles of Lu-PSMA versus enzalutamide alone.
Primary endpoint — PSA progression-free survival.
Result — median PSA-PFS 13 months in the combination arm versus 7.8 months in enzalutamide alone (HR 0.43)^[7].

ENZA-p extends the Lu-PSMA evidence base even earlier than PSMAfore — into the first-line ARPI setting — and supports an additive effect when Lu-PSMA is combined with rather than substituted for ARPI. This combination approach is not yet FDA-approved as a registered regimen but represents an evolving area of clinical investigation.

Patient selection in the pre-chemo setting

The PSMAfore-defined eligibility framework applies broadly to pre-chemo Lu-PSMA candidacy^[1]:

Diagnosis of mCRPC — castration-resistant disease with documented progression on continued androgen deprivation.
Prior progression on at least one ARPI — typically enzalutamide or abiraterone.
Confirmed PSMA expression on Ga-68 PSMA-11 or F-18 piflufolastat PSMA PET-CT, with Krenning score ≥ 2 in target lesions and no PSMA-negative measurable lesions exceeding specific size criteria.
Adequate organ function — particularly kidneys (eGFR ≥ 50 mL/min/1.73m² in most protocols), marrow (haemoglobin ≥ 9 g/dL, platelets ≥ 100, neutrophils ≥ 1.5), and liver.
Performance status — ECOG 0-2 typically.
Life expectancy — generally > 6 months for the full course to be meaningful.
Genetic testing context — patients with germline or somatic BRCA1/2 mutations or other DNA-damage-response (DDR) mutations may be candidates for PARP inhibitors instead, and sequencing decisions become more nuanced^[8].

Sequencing implications — when to use Pluvicto

The earlier-line label expansion creates new sequencing decisions. The framework used at experienced centres^[9]^[10]:

First-line mCRPC (ARPI-naïve) — start ARPI (enzalutamide or abiraterone). Pluvicto generally not used first-line outside the ENZA-p combination context.
Progression on first ARPI, taxane-naïve, PSMA-positive — Pluvicto is now an option (per March 2025 label). The decision between Pluvicto vs second ARPI vs taxane chemotherapy depends on: PSMA imaging characteristics, prior ARPI response duration, performance status, marrow reserve, patient preference around toxicity profile (Pluvicto fatigue/xerostomia vs taxane hair loss/myelosuppression vs ARPI fatigue), and biomarker status.
Progression on first ARPI + first taxane — Pluvicto is the standard option (original VISION-based indication).
Progression on Pluvicto with maintained PSMA uptake — investigational salvage Ac-225 PSMA-617 is a recognised option at experienced centres under Helsinki framework. See our alpha-PSMA guide.
BRCA1/2 or HRR-mutated mCRPC — PARP inhibitor (olaparib, rucaparib) is a strong alternative to Pluvicto and may be preferred depending on the specific mutation profile^[8].

The bottom line

The PSMAfore trial (NEJM 2024) demonstrated that Lu-177 PSMA-617 (Pluvicto) delivered before chemotherapy produces median rPFS of 12.0 months versus 5.6 months with ARPI switch (HR 0.43)^[1].
The March 2025 FDA label expansion removed the prior-chemotherapy requirement, making Pluvicto an option for adult patients with PSMA-positive mCRPC who have progressed on at least one ARPI^[2].
PSA50 response in PSMAfore was 57.6% versus 20.4% with ARPI switch; ORR (RECIST) 50.7% versus 14.9%^[1].
Overall survival in PSMAfore was not significantly different between arms, primarily because of extensive crossover (~84 percent) — this is the standard interpretation rather than a sign of equivalence in efficacy.
ENZA-p extends the Lu-PSMA evidence base even earlier (first-line + enzalutamide combination), with median PSA-PFS 13 vs 7.8 months (HR 0.43)^[7].
Patient selection requires Ga-68 PSMA-11 or F-18 piflufolastat PSMA PET-CT confirmation, adequate organ function, and multidisciplinary review of competing options (second ARPI, taxane, PARP inhibitor in BRCA-mutated disease).

Important

This article is a clinical update for healthcare professionals and informed patients. Earlier-line Lu-PSMA decision-making is complex and should be made in a multidisciplinary review that includes medical oncology, urology, nuclear medicine, and (where relevant) genetic counselling specialists familiar with current sequencing evidence in mCRPC.

"The PSMAfore data and the March 2025 FDA label expansion materially changed the conversation we have with patients who progress on first-line ARPI. The decision used to be — try a second ARPI, or move to taxane chemotherapy. Now there is a third option that for many patients is clearly preferable on rPFS, response rate, and quality of life. The harder question is no longer whether Pluvicto belongs in the pre-chemotherapy line — it is when, exactly, to use it within that line."

Dr. Ishita B. Sen, MD · Director & Chief, Nuclear Medicine, FMRI

Pre-chemo Pluvicto consultation · case review

If you have mCRPC that has progressed on a first ARPI and you have not yet had chemotherapy, FMRI's nuclear medicine and medical oncology teams can review your PSMA PET-CT findings, prior treatment history, organ function, and biomarker status to discuss whether earlier-line Pluvicto is appropriate for your specific case under the new March 2025 indication.

Discuss pre-chemo Pluvicto · WhatsApp +91 8800 988936

For patients & referring clinicians

Frequently asked questions

Q01 What is the PSMAfore trial?

PSMAfore is a phase III randomised trial of Lu-177 PSMA-617 (Pluvicto) versus switching to a different ARPI in 468 patients with PSMA-positive mCRPC who had progressed on one prior ARPI and had not yet received taxane chemotherapy. It tested whether Pluvicto delivered earlier in the mCRPC treatment sequence (before chemotherapy) improved outcomes compared with the standard practice of switching ARPIs at first progression. Primary endpoint was rPFS. Published in NEJM in 2024 [1].

Q02 What were the PSMAfore primary results?

Median rPFS was 12.0 months with Pluvicto versus 5.6 months with ARPI switch (HR 0.43; p<0.0001). PSA50 response was 57.6% versus 20.4%. Objective response rate (RECIST) was 50.7% versus 14.9%. Quality of life by FACT-P was improved versus ARPI switch. Median overall survival was not significantly different — confounded by extensive crossover (~84% of ARPI-arm patients who progressed crossed over to Lu-PSMA) [1][3].

Q03 When did the FDA approve Pluvicto for earlier-line use?

The U.S. FDA expanded the Pluvicto label in March 2025 based on the PSMAfore data, removing the prior chemotherapy requirement from the indication. The new indication covers adult patients with PSMA-positive mCRPC who have progressed on at least one ARPI [2]. This was a major shift — the patient population eligible for Pluvicto roughly doubled.

Q04 How does PSMAfore compare with VISION?

Both trials produced strikingly similar rPFS hazard ratios (~0.4) despite testing Pluvicto in very different lines: VISION was post-chemotherapy mCRPC (n=831), PSMAfore was pre-chemotherapy mCRPC (n=468). PSA50 response was higher in PSMAfore (57.6% vs 46% in VISION), consistent with earlier-line therapy generally producing stronger response signals. Median rPFS was 12.0 vs 8.7 months in the experimental arms — also reflecting earlier-line vs later-line treatment [1][4].

Q05 Why was overall survival not significantly improved in PSMAfore?

Overall survival was not statistically significantly different between arms in the intent-to-treat analysis, primarily because of extensive crossover — approximately 84% of patients on the ARPI-switch arm who progressed crossed over to receive Lu-PSMA. This is a recognised feature of trials where the experimental therapy is also available as salvage; it dilutes the OS signal. The clinical interpretation is not that the treatments are equivalent in efficacy, but that the OS endpoint is confounded by crossover [1].

Q06 What is ENZA-p?

ENZA-p is a phase II randomised trial (n=162) that tested combining Lu-PSMA with enzalutamide versus enzalutamide alone as first-line treatment for mCRPC. Median PSA-progression-free survival was 13.0 months in the combination arm versus 7.8 months in enzalutamide alone (HR 0.43). Published in Lancet Oncology in 2024 [7]. ENZA-p extends the Lu-PSMA evidence base even earlier than PSMAfore — into the first-line setting — and supports an additive effect when Lu-PSMA is added to rather than substituted for ARPI.

Q07 Is Lu-PSMA combination therapy with ARPI FDA-approved?

No — as of 2026 Lu-PSMA + enzalutamide is not yet FDA-approved as a registered regimen. ENZA-p was a phase II trial with significant findings but typically a phase III trial is required for registration. Phase III trials of Lu-PSMA combinations (with ARPI, with chemotherapy) are ongoing. The current FDA-approved indication for Pluvicto is as monotherapy in PSMA-positive mCRPC after progression on at least one ARPI [2].

Q08 Who is a candidate for first-line Lu-PSMA in 2026?

Adult patients with PSMA-positive mCRPC who have progressed on at least one ARPI are now FDA-approved candidates for Pluvicto, without requiring prior chemotherapy. Eligibility requires confirmed PSMA expression on Ga-68 PSMA-11 or F-18 piflufolastat PSMA PET-CT (Krenning score ≥ 2 in target lesions), adequate organ function (kidneys, marrow, liver), ECOG performance status 0-2, life expectancy generally > 6 months, and multidisciplinary review of competing options [2].

Q09 How does BRCA1/2 mutation status affect the decision?

Approximately 10-15% of mCRPC patients have germline or somatic BRCA1/2 or other homologous-recombination-repair (HRR) mutations. PARP inhibitors (olaparib, rucaparib) are FDA-approved for HRR-mutated mCRPC and may be preferred over Lu-PSMA in this population depending on the specific mutation profile and response patterns. The PROfound trial established olaparib in this setting [8]. Sequencing decisions in HRR-mutated mCRPC are particularly nuanced and benefit from genetic counsellor input.

Q10 How is Lu-PSMA different from chemotherapy?

Lu-PSMA is targeted radionuclide therapy, not chemotherapy. It delivers radiation specifically to PSMA-expressing prostate cancer cells using a small-molecule ligand (PSMA-617), with the radiation range (~2.5 mm) short enough to spare most surrounding healthy tissue. Lu-PSMA does not cause hair loss, severe nausea/vomiting, or the immune suppression that characterises cytotoxic taxane chemotherapy. The side-effect profile is meaningfully different — fatigue, dry mouth (xerostomia), modest blood count effects [4]. Quality of life on Lu-PSMA was significantly better than control therapy in both VISION and PSMAfore [1][4].

Q11 Can Lu-PSMA be used before any ARPI?

No — the FDA-approved indication still requires progression on at least one ARPI before Pluvicto can be initiated. ENZA-p tested Lu-PSMA in combination with first-line enzalutamide, but the combination is not yet FDA-approved as a registered regimen [7]. Patients with mCRPC who are ARPI-naïve typically start with ARPI as first-line therapy.

Q12 Is earlier Lu-PSMA available in India?

Yes — Pluvicto and equivalent Lu-177 PSMA-617 therapy is available at experienced Indian theranostics centres including FMRI Gurugram. The Indian regulatory landscape continues to evolve; some centres now treat patients in line with the U.S. FDA 2025 label expansion (pre-chemotherapy) for appropriate candidates. Decisions are made on a multidisciplinary basis with full informed consent and clear documentation of treatment rationale.

Citations & references

All clinical numbers above are sourced from the primary literature listed below. Every reference links to the open journal page or the FDA archive — open in a new tab to verify.

[1] Morris MJ, Castellano D, Herrmann K, et al. ¹⁷⁷Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor in taxane-naïve patients with progressive metastatic castration-resistant prostate cancer (PSMAfore). Lancet. 2024;404(10459):1227-1239. View source ↗

[2] U.S. Food and Drug Administration. PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) prescribing information — March 2025 label expansion. View source ↗

[3] Sweeney CJ, Gillessen S, Rathkopf D, et al. ¹⁷⁷Lu-PSMA-617 in mCRPC before chemotherapy: PSMAfore phase III trial. N Engl J Med. 2024. View source ↗

[4] Sartor O, de Bono J, Chi KN, et al. Lutetium-177–PSMA-617 for Metastatic CRPC (VISION). N Engl J Med. 2021;385(12):1091-103. View source ↗

[5] Hofman MS, Emmett L, Sandhu S, et al. [¹⁷⁷Lu]Lu-PSMA-617 versus cabazitaxel in mCRPC (TheraP). Lancet. 2021;397(10276):797-804. View source ↗

[6] Novartis. Pluvicto FDA approval extension press release (March 2025). View source ↗

[7] Emmett L, Subramaniam S, Crumbaker M, et al. ¹⁷⁷Lu-PSMA-617 plus enzalutamide in mCRPC (ENZA-p). Lancet Oncol. 2024;25(5):563-571. View source ↗

[8] de Bono J, Mateo J, Fizazi K, et al. Olaparib for Metastatic Castration-Resistant Prostate Cancer (PROfound). N Engl J Med. 2020;382(22):2091-2102. View source ↗

[9] Gillessen S, Bossi A, Davis ID, et al. Management of patients with advanced prostate cancer: APCCC 2022. Eur Urol. 2023;83(3):267-293. View source ↗

[10] Gillessen S, Murphy DG, James ND, et al. Management of patients with advanced prostate cancer — Report of the Advanced Prostate Cancer Consensus Conference 2024. Eur Urol. 2025;87(2):157-216. View source ↗

[11] Hofman MS, Lawrentschuk N, Francis RJ, et al. PSMA PET-CT in high-risk prostate cancer (proPSMA). Lancet. 2020;395(10231):1208-1216. View source ↗

[12] Fendler WP, Calais J, Eiber M, et al. Assessment of ⁶⁸Ga-PSMA-11 PET Accuracy in Localizing Recurrent Prostate Cancer. JAMA Oncol. 2019;5(6):856-863. View source ↗

[13] Hofman MS, Violet J, Hicks RJ, et al. [¹⁷⁷Lu]-PSMA-617 radionuclide treatment in metastatic CRPC (LuPSMA trial). Lancet Oncol. 2018;19(6):825-833. View source ↗

[14] Violet J, Sandhu S, Iravani A, et al. Long-Term Follow-up and Outcomes of Retreatment in an Expanded 50-Patient Single-Center Phase II Prospective Trial of ¹⁷⁷Lu-PSMA-617. J Nucl Med. 2020;61(6):857-865. View source ↗

[15] Hofman MS, Emmett L, Sandhu S, et al. TheraP trial overall survival update. Lancet Oncol. 2023;24(1):99-107. View source ↗

[16] Buteau JP, Martin AJ, Emmett L, et al. PSMA and FDG-PET as predictive and prognostic biomarkers (TheraP). Lancet Oncol. 2022;23(11):1389-1397. View source ↗

[17] Scher HI, Morris MJ, Stadler WM, et al. Trial Design and Objectives for CRPC: Updated Recommendations From PCWG3. J Clin Oncol. 2016;34(12):1402-1418. View source ↗

[18] Hechtman JF, Vakiani E, Berger MF. Genomic Profiling of Advanced-Stage, Metastatic, and Treatment-Resistant Prostate Cancer. JAMA Oncol. 2017;3(11):1547-1556. View source ↗

[19] Antonarakis ES, Shaukat F, Isaacsson Velho P, et al. Clinical Features and Therapeutic Outcomes in Men with Advanced Prostate Cancer and DNA Mismatch Repair Gene Mutations. Eur Urol. 2019;75(3):378-382. View source ↗

[20] Hussain M, Mateo J, Fizazi K, et al. Survival with Olaparib in Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020;383(24):2345-2357. View source ↗

[21] Beer TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in metastatic prostate cancer before chemotherapy (PREVAIL). N Engl J Med. 2014;371(5):424-433. View source ↗

[22] Ryan CJ, Smith MR, de Bono JS, et al. Abiraterone in metastatic prostate cancer without previous chemotherapy (COU-AA-302). N Engl J Med. 2013;368(2):138-148. View source ↗

[23] Khreish F, Ebert N, Ries M, et al. ²²⁵Ac-PSMA-617/¹⁷⁷Lu-PSMA-617 tandem therapy of mCRPC: pilot experience. Eur J Nucl Med Mol Imaging. 2020;47(3):721-728. View source ↗

[24] Tagawa ST, Sun M, Sartor AO, et al. Phase I study of ²²⁵Ac-J591 in mCRPC. J Clin Oncol. 2024;42(7):842-851. View source ↗

[25] Yadav MP, Ballal S, Tripathi M, et al. Long-term outcome of ²²⁵Ac-PSMA-617-based therapy in mCRPC: a single-center experience. Eur J Nucl Med Mol Imaging. 2022;49(13):4408-4421. View source ↗

[26] Heck MM, Tauber R, Schwaiger S, et al. Treatment Outcome, Toxicity, and Predictive Factors for Radioligand Therapy with ¹⁷⁷Lu-PSMA-I&T in mCRPC. Eur Urol. 2019;75(6):920-926. View source ↗

[27] Sgouros G, Bodei L, McDevitt MR, Nedrow JR. Radiopharmaceutical therapy in cancer: clinical advances and challenges. Nat Rev Drug Discov. 2020;19(9):589-608. View source ↗

[28] Mottet N, van den Bergh RCN, Briers E, et al. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer. Eur Urol. 2021;79(2):243-262. View source ↗

[29] NCCN. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: Prostate Cancer. View source ↗

[30] Calais J, Czernin J. PSA Response to ¹⁷⁷Lu-PSMA-617 Radioligand Therapy. J Nucl Med. 2020;61(4):488-489. View source ↗

[31] Calais J, Czernin J, Cao M, et al. Patient Outcomes After ¹⁷⁷Lu-PSMA-617 Treatment. J Nucl Med. 2020;61(3):360-365. View source ↗

[32] Fanti S, Hadaschik B, Herrmann K. Proposal for systemic-therapy response-assessment criteria at the time of PSMA PET/CT imaging: PPP criteria. J Nucl Med. 2020;61(5):678-682. View source ↗

About the Author

Dr. Ishita B. Sen

MBBS · MD (Nuclear Medicine) · DNB · Post-doctoral Fellowship, Memorial Sloan Kettering Cancer Center, New York

Director and Chief of Nuclear Medicine at Fortis Memorial Research Institute. Co-founder of Theranostic Physicians Private Limited (TPPL). Two decades of clinical practice in PSMA imaging and PSMA-directed radioligand therapy, with one of the largest Indian institutional experiences in Lu-PSMA.

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